杭州招聘

Job responsibilities include but not limited to:

Top Job Responsibilities:

1.        Provide project leadership supporting IND enabling and late stage product development CMC activities.

2.        Participate and show leadership in establishing WuXi Biologics CMC strategies and recommendation in supporting all ongoing projects in CMC development.

3.        Leading CMC projects with good understanding of potential technical challenges and meeting the regulatory requirements and ICH’s quality and efficacy guidelines. 

4.        Collaborate with CMC functional areas to ensure successful execution of various CMC projects, and delivery of results on time and within budget.

5.        Chart the course, track progress against goals and outline key strategic events for project. Manage project scope definitions and changes, and budgets. 

6.        Serve as the center of solution. Address any challenges and issues that arise.  Make hard decisions. 

7.        Engage efficiently with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines.

8.        Build a solid communication with client to ensure alignment between WuXi Biologics and clients. 

9.        Provide leadership in development and manufacturing alliance management, product development and manufacturing strategy

10.    Assist in recruiting, training and retaining a high performance CMC team to ensure best quality services and leadership in CMC management functions worldwide.

11.    Support BD efforts and proposal writing team to enhance current service offering and develop new clients. 

12.    Develop and manage operational budgets and supervise teams to ensure IP and EHS compliance. 

Opportunities:

?           Broaden personal knowledge and experience in the field of biologics

?           Integrate cross-functional knowledge in real life drug development and commercialization process

?           Develop leadership skill to facilitate contributions from different functions

?           Develop well-around knowledge in preparation for executive opportunities

Required Qualifications:

?           Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Science or related major with 8+ years of applicable work experience.

?           Good knowledge in CMC strategy, risk and resource management, regulatory requirements and ICH guidelines.

?           Strategic view and leadership abilities as well as hands on problem solving skills. Experience in managing projects is required.

?           Excitement about the vision and mission of WuXi Biologics. 

Preferred (but not required) Qualifications:

?           Experience in two or more functional areas in Project Management, Cell Line Development, Cell Culture, Purification, Analytical, Formulation, Manufacturing, Manufacturing Support, QC or QA in the biologics industry.

?           Experience with staff management and/or CMC team management.

?           Ability to effectively work across all levels, functions, sites and companies.  Excellent verbal and written communication skills in both English and Chinese.

?           Experience in writing regulatory documents and submissions and ability to work on multiple CMC projects at a time.

上海药明生物技术有限公司诚聘